Serious Risks Associated with Medtronic’s MindFrame Capture LLP Revascularization Device
The United States Food and Drug Administration (FDA) has issued a Class I recall of the MindFrame Capture LLP Revascularization Device manufactured by Medtronic. The device reportedly contains a material that can break or separate when the product is being used causing it to remain in a patient’s bloodstream. This defect could lead to severe injuries or death in patients.
MindFrame Capture LP Revascularization Device Uses
The device subject to the recall is a used to restore a patient’s blood flow or to remove blood clots located in the brain when a patient is suffering from an acute ischemic stroke. Ischemic strokes are the most common type of stroke. About 88% of people who experience strokes have ischemic strokes. The MindFrame device is one option physicians use when IV t-PA therapy fails to work on a patient having a stroke.
IV t-PA stands for “tissue plasminogen activator” and is a medication that is administered intravenously to patients suffering from ischemic strokes. The medication has the ability to save the life of a person suffering a stroke and can reduce the symptoms and damage caused by a stroke. This medication is only useful if it is given to the patient in the first 3 hours following the onset of the stroke, although, in some instances, it may be given within 4.5 hours.
If this medication, which is the first and preferred form of treatment, fails then doctors must resort to removing the clot through other means, such as the MindFrame.
The Defect is Extremely Dangerous
The Medtronic device uses a wire material that has shown that it could break or become detached from the device and remain in the patient’s bloodstream. If this occurs, the device, or the physician’s efforts to remove the device, could cause injuries to the patient, including “bleeding, additional blockage of blood vessels, more severe strokes, or death.”
The severe risk posed by this device is the reason that the FDA issued a Class I recall. Class I recalls are used in the most severe cases when the item being recalled poses a risk of severe injuries and death.
Which Devices are Subject to the Recall
The recall applies to devices that were manufactured between February 3, 2016, and January 14, 2018. There were 529 devices recalled in the United States. The recall was issued on February 26, 2018. The company sent out urgent notices to the customers who purchased the affected devices. Customers were advised that they should remove the devices from their inventory and that they should return them to Medtronic.
Impacted Patients Need Monitoring
Medtronic sent a second urgent recall notice to the customers on April 2, 2018. In this notice, the company advised health care providers on how to manage patients who were treated using these devices. The physicians were instructed to follow up with patients and to consider repeating imaging tests and the possibility of using antiplatelet therapy for those affected.
Product Liability and Medical Devices
Patients rely on medical devices, which can be used to save lives. However, medical devices can be defective, and in some instances can cause damage rather than doing any good for the patient. If a patient is injured by a flawed medical device, the manufacturer or the seller of that product can be held liable for the harm that they caused.
Lawsuits regarding defective medical devices are a type of product liability claim. Product liability claims arise from situations where a product has a defect, and the defect injures the consumer when the product is being used for the purpose for which it was intended.
Products can be defective because of a flaw in their design, because something went wrong during the manufacturing process, or because the company failed to warn about a known risk or marketed the product for a use for which it was not suited.
Is the Company Protected Because They Recalled the Device?
When a company issues a recall, this does not absolve them of their liability to people injured by a product. If a company does not recall a product when they should have, and someone is injured, then this could mean that the company will face more severe punishment. Additionally, a recall is not necessarily an admission of guilt that will automatically make a company liable for any injuries.
Typically, recalls are issued by the company, but the FDA has the power to issue recalls if a company refuses to do so and the product is dangerous. The FDA rarely needs to take this action.
The Statute of Limitations in Medtronic MindFrame Capture LLP Revascularization Device Lawsuits
A statute of limitations gives plaintiffs a certain amount of time in which to file their lawsuits. The amount of time offered is often two years, but it varies depending on the state. The time starts to run at the time of the injury, or at the time that the injury should have been discovered.
There are also sometimes statutes of repose which give a person a certain amount of time to file a claim following the purchasing of a product. The statute of repose gives more time than the statute of limitations.
For decades, Parker Waichman LLP’s attorneys have been representing clients who have been injured by defective medical devices. Medical device litigation often involves complicated issues and is considered a specialized area within the broader field of product liability. We have recovered more than $2 billion in compensation for our personal injury clients.
Contact us today at 1-800-YOURLAWYER (1-800-968-7529) for a free consultation with one of our Medtronic MindFrame Capture LLP Revascularization Device lawsuit attorneys.
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